Hobson Prior are currently seeking a Director of Medical Writing to join a biopharmaceutical research organisation who specialize in oncology product development and pioneering medicines that are used all over the world.

Job Responsibilities:

• Responsible to lead, manage, and organise all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for programs/compounds within the assigned Therapeutic Area.
• Oversee contract medical writing resources as required to ensure timely completion of assigned projects which may include review of scopes of work (content and financial) within the assigned Therapeutic Area.
• Represent as an active member of the Medical Writing Leadership Team helping to define the strategic direction and process improvements both within MW and cross-functionally.
• You will have direct people management responsibility of writers including providing mentoring and facilitating employee professional development.
• Ensure development of regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes.
• Actively participate in project and/or study team meetings as necessary to provide input regarding medical writing deliverables, timelines, and any processes needed for the completion of regulatory documents.

Key Skills:

• Ability to independently lead the clinical portions of a marketing authorization submission including the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach.
• Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
• Ability to interact effectively with team members/leaders and senior leaders.
• Prior management experience preferred. Ability and desire to manage people and provide active support in all aspects of the job.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.

Requirements:

• Advanced degree in a relevant scientific/clinical/regulatory field preferred. Bachelor's degree required.
• A minimum of 10 years writing experience in the biopharmaceutical/CRO industry required.
• Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
• Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
• Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.